EU plans changes to pharma law to avoid medicine shortages Reuters Jan 18, 2023 Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency (EMA) says.
EMA seeks to issue guidance on liver damage from Novartis’s gene therapy Reuters Jan 16, 2023 The statement follows recent deaths due to liver failure after treatment with the gene therapy, the EMA said
EC approves expanded indication for Merck’s Pneumococcal 15-valent Conjugate Vaccine EP News Bureau Oct 27, 2022 The approval facilitates availability of Vaxneuvance for this population in all 27 European Union (EU) member states plus Iceland,…
EMA recommends Moderna’s updated Omicron-tailored vaccine Reuters Oct 20, 2022 The agency also authorised Pfizer-BioNTech's and Moderna's vaccines for children as young six months
Pfizer announces positive results from phase-III study in 20-valent Pneumococcal Conjugate Vaccine… EP News Bureau Sep 21, 2022 The company intends to file for regulatory approval in the EU in the next few months
EMA validates Gilead’s Marketing Authorisation Application for Lenacapavir EP News Bureau Aug 23, 2022 Lenacapavir is an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
AstraZeneca gets EU backing for targetted breast cancer therapies Reuters Jun 28, 2022 The drug, which has received a similar recommendation in the US in March, is a key asset for AstraZeneca
EMA increases general, non-pharmacovigilance fees by 0.3 per cent and 5.3 per cent from 1st April,… EP News Bureau Apr 4, 2022 Every year, the agency adjusts its fees on 1st April, in line with the European Union (EU) inflation rate for the previous year
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV… EP News Bureau Apr 1, 2022 Celerity Pharma uses Biocon Biologics’ insulin drug substance to develop the product
Valneva now expects recommendation on COVID-19 vaccine by April Reuters Mar 14, 2022 It cited “a small set of additional questions” from the EMA as reason for the delay, adding it was set to respond within days